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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K903674
Device Name MODEL 295 ELECTRONIC RESPIROMETER
Applicant
National Medical Sales, Inc.
26086 Getty
Laguna Niquel,  CA  92677
Applicant Contact WILLIAM D BURCH
Correspondent
National Medical Sales, Inc.
26086 Getty
Laguna Niquel,  CA  92677
Correspondent Contact WILLIAM D BURCH
Regulation Number868.1850
Classification Product Code
BZK  
Date Received08/13/1990
Decision Date 01/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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